Tukol®

Tukol®
SPL v2
SPL
SPL Set ID aedce1f9-4902-4c51-92e0-6056196394c2
Route
ORAL
Published
Effective Date 2024-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (32.5 mg) Dextromethorphan (1 mg) Guaifenesin (20 mg) Phenylephrine (0.5 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Sodium Benzoate Sucralose

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-21

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 20 mL) Purposes
Acetaminophen 650mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Directions
  • do not take more than directed
  • Do not take more than 4 doses in 24 hours.
  • This adult strength product is not intended for use in children under 12 years of age
  • Dose as follows or as directed by a doctor
  • Use dose cup provided
age dose
adults and children 12 years and older 20 mL every 4 hours
children under 12 years of age do not use
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash.

If skin reaction occurs, stop use and seek medical help right away.

Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product.
Other Information
  • each 20 mL contains: sodium 10 mg
  • store between 15-30°C (59-86°F), do not refrigerate
Sore Throat Warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vominting, consult a doctor promptly.

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-877-994-3666

Monday to Friday from 8 AM to 6 PM, Central time.

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • cough comes back or occuurs with fever, rash, or headache that lasts
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 177 Ml Bottle Carton

Tukol®

MAX ACTION

COLD, FLU AND SORE THROAT

Acetaminophen / Dextromethorphan HBr/

Guaifenesin / Phenylephrine HCl

Ages

12+

MAX

STRENGTH

Relieves:

  • MINOR ACHES & PAIN
  • FEVER
  • NASAL & CHEST CONGESTION
  • COUGH

6 FL OZ (177 mL)


Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 20 mL) Purposes
Acetaminophen 650mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Directions
  • do not take more than directed
  • Do not take more than 4 doses in 24 hours.
  • This adult strength product is not intended for use in children under 12 years of age
  • Dose as follows or as directed by a doctor
  • Use dose cup provided
age dose
adults and children 12 years and older 20 mL every 4 hours
children under 12 years of age do not use
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash.

If skin reaction occurs, stop use and seek medical help right away.

Liver Warning (Liver warning)

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product.
Other Information (Other information)
  • each 20 mL contains: sodium 10 mg
  • store between 15-30°C (59-86°F), do not refrigerate
Sore Throat Warning (Sore throat warning)

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vominting, consult a doctor promptly.

Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-877-994-3666

Monday to Friday from 8 AM to 6 PM, Central time.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • cough comes back or occuurs with fever, rash, or headache that lasts
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 177 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton)

Tukol®

MAX ACTION

COLD, FLU AND SORE THROAT

Acetaminophen / Dextromethorphan HBr/

Guaifenesin / Phenylephrine HCl

Ages

12+

MAX

STRENGTH

Relieves:

  • MINOR ACHES & PAIN
  • FEVER
  • NASAL & CHEST CONGESTION
  • COUGH

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

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